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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE Back to Search Results
Model Number 720081-01
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2022
Event Type  Injury  
Event Description
It was reported that during the implant surgery, the tactra was removed and replaced due to a size measurement error.The surgery was successfully completed with a smaller device and no patient complications were reported.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this tactra underwent a thorough analysis.The cylinders were visually and microscopically examined.No anomalies were found with the device.Based on the information available and analysis results, the product analysis was not able to identify the cause that could have contributed to the reported clinical observation of sizing issue.The investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation, based on physician improper sizing of cylinder during implantation.
 
Event Description
It was reported that during the implant surgery, the tactra was removed and replaced due to a size measurement error.The surgery was successfully completed with a smaller device and no patient complications were reported.
 
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Brand Name
TACTRA MALLEABLE PENILE PROTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15995856
MDR Text Key305602816
Report Number2124215-2022-53108
Device Sequence Number1
Product Code FAE
UDI-Device Identifier08714729979357
UDI-Public08714729979357
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K183619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number720081-01
Device Catalogue Number720081-01
Device Lot Number0028545973
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2022
Initial Date FDA Received12/16/2022
Supplement Dates Manufacturer Received01/26/2023
Supplement Dates FDA Received02/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
Patient SexMale
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